Skin protectant spray compositions

ABSTRACT

A liquid, water-repellent, substantially anhydrous, spray-pumpable skin protectant composition is disclosed. The composition is designed for spraying directly onto skin, has suitable adherence to the skin, and resists running. The composition contains one or more actives for whichever indication the composition has been formulated, one or more rheology modifiers, and a carrier. The rheology modifiers help give the composition rheological properties such that it can be sprayed using a spray pump dispenser (i.e., a propellant-free, non-pressurized dispenser) but still resist running after it has been applied to the skin. The rheological modifiers can be waxes and/or associative thickeners such as some forms of silica. The carrier can be mineral oil or a mineral oil replacement (e.g., isohexadecane, cyclomethicone). Film-forming components also help the composition resist running. One indication for which the composition may be formulated is diaper rash. The diaper rash composition is designed for spraying onto the skin of a baby or other human (e.g., incontinent adult) for treating diaper rash. The active ingredient for diaper rash may be dimethicone and preferably also zinc oxide.

BACKGROUND OF THE INVENTION

1. Technical Field

This invention concerns topical formulations and, more particularly,topical skin protectant formulations that can be sprayed.

2. Background

Drugs and other substances are often applied to human skin to protect itfrom harmful stimuli. The U.S. Food And Drug Administration (“FDA”) hasin the past defined a “skin protectant” as a drug that protects injuredor exposed skin or mucous membrane surfaces from harmful or annoyingstimuli (21 CFR § 347.3 (1983)). Thus, a “skin protectant” can be usedto protect and/or treat skin in connection with various indications,including diaper rash; minor burns; cuts; scrapes; sunburn; chaffed,chapped, cracked, or windburned skin or lips; skin irritation; andoozing and/or weeping of skin caused by poison ivy, poison oak, and/orpoison sumac.

The skin of infants is known to be highly sensitive, particularly tochemical substances. One common skin problem of infants is diaperdermatitis, more commonly called “diaper rash.” “Diaper rash” has beendefined by the FDA as an inflammatory skin condition in the diaper area(perineum, buttocks, lower abdomen, and inner thighs) caused by one ormore of the following factors: moisture, occlusion, chaffing, continuedcontact with urine or feces or both, or mechanical or chemicalirritation (21 CFR § 347.3 (1990)), and that definition will be usedherein. The FDA has also indicated that mild diaper rash appears assimple erythema and that more severe conditions may be accompanied bypapules, vesicles, oozing, and ulceration. Adults (e.g., incontinentadults) may also suffer from diaper rash.

Strategies for dealing with diaper rash include removing the source ofirritation, reducing the immediate skin reaction, relieving discomfort,and preventing secondary infection. Many products used in treatingdiaper rash are designed to provide a barrier between the skin and thewaste products. Known barrier ingredients include zinc oxide andpetrolatum. Barrier products containing oily substances such aspetrolatum may feel greasy, may be difficult to apply because of theirhigh viscosity, and may not be easily removed from hands that apply theproducts or from the infant's skin. Clean-up of these products from thehands and from the infant's skin may be regarded by some astime-consuming, messy, and inconvenient.

The FDA will allow claims to be made that the following substances areuseful as skin protectants provided, among other things, that thosesubstances are used at FDA-specified concentration levels: mineral oil,dimethicone, zinc oxide, allantoin, calamine, kaolin, petrolatum, whitepetrolatum, cod liver oil, lanolin, talc, topical starch, aluminumhydroxide gel, cocoa buffer, glycerine, shark liver oil, zinc acetate,and zinc carbonate, all of which will be referred to herein as “activeingredients for protecting skin” (21 CFR § 347.10 (1983 and 1990)). Asused herein, the terms “protecting skin,” “protecting the skin,” and“protecting human skin” are synonymous and each include protectingand/or treating skin in connection with various indications involvingthe skin, including diaper rash; minor burns; cuts; scrapes; sunburn;chaffed, chapped, cracked, or windburned skin or lips; skin irritation;and oozing and/or weeping of skin caused by poison ivy, poison oak,and/or poison sumac.

The FDA will allow claims to be made that the following substances areuseful in treating diaper rash provided, among other things, that thosesubstances are used at FDA-specified concentration levels: mineral oil,dimethicone, zinc oxide, allantoin, calamine, kaolin, petrolatum, whitepetrolatum, cod liver oil, lanolin, talc, and topical starch, all ofwhich will be referred to herein as “active ingredients for treatingdiaper rash” (21 CFR § 347.10 (1983 and 1990)). For example, assumingall the other requirements are met, the FDA will allow a claim to bemade that a composition containing dimethicone is useful for treatingdiaper rash if the dimethicone concentration is from 1% w (percent byweight) to 30% w. A similar claim can be made for a compositioncontaining zinc oxide if the zinc oxide concentration is from 1% w to40% w. A similar claim can be made for a composition containing mineraloil if the mineral oil concentration is from 50% w to 100% w. As usedherein, the term “treating diaper rash” includes treating an existingdiaper rash condition or preventing a diaper rash condition or both.

Compositions that may contact the skin and may contain zinc oxide,and/or mineral oil, and/or silicon dioxide (silica), and/or dimethiconeor other silicone compounds, some of which compositions may be in theform of aerosols or sprays and some of which compositions may be usedfor treating diaper rash, include those compositions referred to in U.S.Pat. Nos. Re. 33,107, 2,843,522, 3,770,648, 3,935,862, 4,1043,077,4,196,218, 4,273,786, 4,278,658, 4,329,366, 4,389,418, 4,514,383,4,556,560, 4,569,839, 4,574,082, 4,672,074, 4,725,438, 4,800,076,4,816,254, 4,842,593, 4,847,071, 4,911,932, 4,933,330, 4,938,960,4,996,238, 4,996,239, 5,043,359, 5,085,856, 5,137,714, 5,208,031,5,210,102, 5,232,691, 5,234,689, 5,266,318, 5,362,488, 5,389,204,5,436,007 5,527,519, 5,543,135, 5,545,673, 5,558,872, 5,573,753,5,576,006, 5,603,863, 5,616,331, 5,635,191, 5,643,588, 5,652,274,5,662,937, 5,665,426, 5,730,993, 5,733,895, 5,744,146, 5,756,082,5,756,110, 5,762,945, 5,776,440, 5,834,290, 5,861,143, 5,861,144,5,861,146, 5,863,522, 5,869,061, 5,869,062, 5,869,071, 5,874,094,5,885,599, 5,914,101, 5,939,053, 5,945,211, 5,958,397, 5,961,961,5,962,441, 5,965,137, 5,965,610, 5,968,531, and 5,972,359. (All of thethese documents and any other documents discussed or otherwisereferenced or identified herein are incorporated herein in theirentireties for all purposes.)

Compositions containing zinc oxide that may contact the skin includethose referred to in U.S. Pat. Nos. 2,843,522, 3,770,648, 4,034,077,4,278,658, 4,389,418, 4,556,560, 4,569,839, 4,672,074, 4,816,254,4,911,932, 4,933,330, 5,085,856, 5,208,031, 5,232,691, 5,527,519,5,543,135, 5,545,673, 5,573,753, 5,603,863, 5,616,331, 5,652,274,5,662,937, 5,665,426, 5,730,993, 5,733,895, 5,744,146, 5,756,110,5,762,945, 5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522,5,869,062, 5,874,094, 5,885,599, 5,914,101, 5,939,053, 5,945,211,5,961,961, 5,962,441, 5,965,610, 5,968,531, and 5,972,359.

Some of the compositions containing zinc oxide may be sprayable (with orwithout a propellant). See, e.g., U.S. Pat. Nos. 3,770,648, 4,278,658,4,933,330, 5,652,274, 5,733,895, 5,834,290, 5,861,143, 5,861,144,5,861,146, 5,863,522, 5,885,599, 5,939,053, 5,945,211, 5,962,441,5,965,610, and 5,972,359.

Some of the compositions containing zinc oxide may contain small zincoxide particles (e.g., less than 1 micron). See, e.g., U.S. Pat. Nos.5,543,135, 5,527,519, 5,573,753, 5,603,863, 5,616,331, 5,730,993,5,756,110, 5,861,143, 5,861,144, 5,861,146, 5,914,101, 5,945,211,5,961,961, and 5,972,359.

Topical compositions for treating diaper rash containing zinc oxideinclude DESITIN® Ointment and DESITIN® Creamy Ointment, both marketed byPfizer Inc, the assignee of the present application. DESITIN® Ointmentcontains about 40% w zinc oxide and other ingredients, including whitepetrolatum, cod liver oil, lanolin, talc, and about 5% w water. DESITIN®Creamy Ointment contains about 10% w zinc oxide and other ingredients,including mineral oil, mineral wax, dimethicone, cyclomethicone, whitepetrolatum, white wax, and over 30% w water.

Other diaper rash, incontinence/dermatitis, diaper-treating, and babytreatment compositions include those referred to in U.S. Pat. Nos. Re.33,107, 2,843,522, 3,770,648, 3,935,862, 4,034,077, 4,273,786,4,329,366, 4,556,560, 4,816,254, 4,842,593, 4,911,932, 4,996,238,4,996,239, 5,362,488, 5,436,007, 5,576,006, 5,558,872, 5,635,191,5,643,588, 5,652,274, 5,762,945, 5,834,290, 5,869,071, and 5,945,211.

Some of those diaper rash, incontinence/dermatitis, diaper-treating, andbaby treatment compositions may form a film when they are topicallyapplied and may be resistant to wetting by moisture. See, e.g., U.S.Pat. No. 4,996,238 (column 2, line 20 and following) and U.S. Pat. No.4,996,239 (column 2, line 40 and following).

Some of those diaper rash, incontinence/dermatitis, diaper-treating, andbaby treatment compositions may contain film-forming agents. See, e.g.,U.S. Pat. No. 4,996,238 (column 2, line 42 and following), U.S. Pat. No.4,996,239 (column 2, line 63 and following), U.S. Pat. No. 5,635,191(column 18, line 34), and U.S. Pat. No. 5,643,588 (column 18, line 47).

Some of those diaper rash, incontinence/dermatitis, diaper-treating, andbaby treatment compositions may be sprayable (with or without apropellant). See, e.g., U.S. Pat. Nos. Re. 33,107, 3,770,648, 3,935,862,4,273,786, 4,329,366, 4,842,593, 5,436,007, 5,576,006, 5,635,191,5,643,588, 5,652,274, 5,869,071, and 5,945,211.

U.S. Pat. No. Re. 33,107 refers to sprays that may contain mineral oilfor treating skin conditions such as dermatitis.

U.S. Pat. No. 3,770,648, assigned on its face to Bristol-Myers Company,refers to substantially non-aqueous quick-breaking aerosol foamingcompositions containing silicone compounds (e.g., dimethyl siliconefluids), foamable organic liquids (e.g., mineral oil), and a high vaporpressure propellant system (e.g., fluorocarbons). Example 2 of thepatent refers to what is called “DESITIN® baby foam,” containing zincoxide (about 4.2% w), mineral oil (about 71.7% w), a silicone, and FREON12 fluorocarbon propellant.

U.S. Pat. Nos. 3,935,862 and 4,273,786 refer to compositions containingamino acid compounds to inhibit the formation of ammonia and thereforetreat diaper rash. The compositions may contain solid diluents such asstarch and talc and may also contain silicone-type fluids such aspolysiloxane fluid. Although mineral oil is referred to in some of thenon-sprayable compositions exemplified in the patents, the onlysprayable composition (Example H) contains micropulverized talc, anamino acid salt, fragrance, anhydrous ethanol, isopropyl myristate, andtwo FREON propellants.

U.S. Pat. No. 4,329,366 refers to compositions containingacylaminophenols that can be used to treat various conditions, includingdiaper rash. Although mineral oil is referred to in some of thenon-sprayable formulations exemplified, the two sprayable formulations(Formulations F and L) use alcohol and propellants and at least one ofthem (Formulation F) contains water.

U.S. Pat. No. 4,842,593 refers to a pH control system that can besprayed onto an article used to prevent or reduce diaper rash. Thefibers of the article may be impregnated with silica.

U.S. Pat. No. 5,436,007 refers to a diaper rash lotion that may besprayed containing dimethicone (e.g., from 1% w to 30% w), water (e.g.,from 50% w to 95% w), and an emulsifier (e.g., from 1% w to 10% w). Thepatent also refers to a diaper rash cream that may contain a linearpolydimethylsiloxane (e.g., 20% w), a light mineral oil (e.g., 4% w),emulsifier (e.g., 8% w), and water (e.g., over 40% w). Stearic acid,which is said to function as a thickener, and aloe may also be used inthe lotion and the cream. See, e.g., column 7, line 6, to column 10,line 26.

U.S. Pat. No. 5,576,006 refers to antibacterial compositions that can beused to deodorize footwear and to treat diaper rash. Although thefootwear deodorizing compositions can be sprays, it appears that thecompositions intended for use on infants are “body preparations andpowders,” which may contain talc (column 3, lines 47-63, and Example 3).The sprays exemplified contain water.

U.S. Pat. Nos. 5,635,191 and 5,643,588 refer to a diaper having atopsheet coated with a composition containing emollients (such asmineral oil, petrolatum or mineral wax, and polysiloxanes) and otheringredients (such as viscosity modifiers and film formers). Thecomposition may be sprayed onto the topsheet. According to the patents,the composition on the diaper topsheet is transferred to the wearer'sskin and those topsheets provide “BM [bowel movement] cleaning,therapeutic or protective lotion coating benefits” (U.S. Pat. No.5,635,191, column 2, line 64, to column 3, line 52; and U.S. Pat. No.5,643,588, column 2, line 62, to column 3, line 51). The composition is“solid” or “semisolid” at 20 degrees Centigrade (U.S. Pat. No.5,635,191, column 9, lines 35-67; and U.S. Pat. No. 5,643,588, column 9,line 39, to column 10, line 4) and is “substantially free of water”(U.S. Pat. No. 5,635,191, column 10, lines 43-54, and U.S. Pat. No.5,643,588, column 10, lines 48-59).

U.S. Pat. No. 5,652,274 refers to therapeutic wound healingcompositions. Compositions for treating diaper dermatitis are discussed,for example, at column 11, 5 lines 31-49; column 15, lines 39-61; column26, lines 5-26; and column 138, line 52, to column 145, line 4. Thosecompositions may contain zinc oxide. At least some compositions may besprayed (for example, the formulations of Embodiment One; see column 42,line 26).

Some of the compositions may contain petrolatum, mineral oil, andvitamin E (see, e.g., column 66, lines 35-49).

U.S. Pat. No. 5,869,071 refers to a spray composition for incontinentpatients that “cleanses, moisturizes and leaves a protective petrolatumbarrier against wetness and irritants in one step” (column 1, lines58-63). The composition is said to be an emulsion of water andpetrolatum (or petroleum jelly) and may contain dimethicone,cyclomethicone, mineral oil, vitamin E, and aloe.

U.S. Pat. No. 5,945,211 refers to a composite to which zinc oxideparticles are adhered. The composite may be a diaper and the zinc oxidemay be deposited on the composite from an aqueous medium (e.g., byspraying an aqueous suspension of zinc oxide).

Sprayable (with or without a propellant) compositions that may contactthe skin and that may contain dimethicone or other silicon compoundsinclude those referred to in U.S. Pat. Nos. 3,770,648, 3,935,862,4,273,786, 4,514,383, 4,847,071, 4,933,330, 5,137,714, 5,266,318,5,389,204, 5,436,007, 5,635,191, 5,643,588, 5,733,895, 5,776,440,5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,869,071,5,885,599, 5,939,053, 5,962,441, 5,965,610, and 5,972,359.

Compositions containing some form of silica (silicon dioxide) includethose referred to in U.S. Pat. Nos. 4,574,082, 4,800,076, 4,996,238,4,996,239, 5,137,714, 5,208,031, 5,527,519, 5,543,135, 5,573,753,5,603,863, 5,616,331, 5,733,895, 5,756,082, 5,756,110, 5,834,290,5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,914,101,5,939,053, 5,968,531, and 5,972,359. Some forms of silica are said to beusefull as thickeners. See, e.g., U.S. Pat. Nos. 4,996,238 and4,996,239. Some of those compositions containing some form of silicaalso may contain zinc oxide. See, e.g., U.S. Pat. Nos. 5,208,031,5,527,519, 5,543,135, 5,573,753, 5,603,863, 5,616,331, 5,733,895,5,756,110, 5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522,5,885,599, 5,914,101, 5,939,053, 5,968,531, and 5,972,359.

Some of those compositions containing silica (with or without zincoxide) may be sprayable. See, e.g., U.S. Pat. Nos. 5,137,714, 5,733,895,5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599,5,939,053, and 5,972,359.

Some sprayable compositions may contain aloe and/or a form of vitamin E.See, e.g., U.S. Pat. Nos. 4,847,071, 5,266,318, 5,436,007, 5,861,143,5,861,144, 5,861,146, 5,869,071, 5,885,599, 5,965,137, 5,965,610, and5,972,359. Some of the composition containing aloe and/or a form ofvitamin E may be for treating diaper rash and/orincontinence/dermatitis. See, e.g., U.S. Pat. Nos. 5,436,007 and5,869,071.

Compositions containing (a) mineral oil or petrolatum, (b) zinc oxide,and (c) dimethicone or other silicone ingredient include those referredto in U.S. Pat. Nos. 3,770,648, 4,389,418, 4,556,560, 4,569,839,4,911,932, 4,933,330, 5,085,856, 5,208,031, 5,232,691, 5,543,135,5,603,863, 5,616,331, 5,665,426, 5,730,993, 5,733,895, 5,744,146,5,756,110, 5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522,5,885,599, 5,914,101, 5,939,053, 5,961,961, 5,962,441, 5,965,610, and5,972,359. Some of those compositions may be sprayable (with or withouta propellant). See, e.g., U.S. Pat. Nos. 3,770,648, 4,933,330,5,733,895, 5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522,5,885,599, 5,939,053, 5,962,441, 5,965,610, and 5,972,359. Some of thosecompositions may be for treating diaper rash. See, e.g., U.S. Pat. Nos.4,556,560 and 4,911,932.

Some of those compositions containing (a) mineral oil or petrolatum, (b)zinc oxide, and (c) dimethicone or other silicone ingredient may alsocontain silica. See, e.g., U.S. Pat. Nos. 5,208,031, 5,543,135,5,603,863, 5,616,331, 5,733,895, 5,756,110, 5,834,290, 5,861,143,5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,914,101, 5,939,053, and5,972,359. Some of those compositions may be sprayable (with or withouta propellant). See, e.g., U.S. Pat. Nos. 5,733,895, 5,834,290,5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,939,053, and5,972,359.

Some of those compositions containing (a) mineral oil or petrolatum, (b)zinc oxide, and (c) dimethicone or other silicone ingredient may alsocontain wax. See, e.g., U.S. Pat. Nos. 4,389,418, 4,556,560, 4,569,839,4,911,932, 4,933,330, 5,085,856, 5,208,031, 5,232,691, 5,616,331,5,665,426, 5,730,993, 5,733,895, 5,744,146, 5,834,290, 5,863,522,5,939,053, and 5,961,961. Some of those compositions may be sprayable(with or without a propellant). See, e.g., U.S. Pat. Nos. 4,933,330,5,733,895, 5,834,290, 5,863,522, and 5,939,053.

Despite all the work done in this technical area, the need still existsfor a safe and effective liquid skin protectant composition that isliquid, is water-repellent, substantially anhydrous, can be applieddirectly to the skin, quickly, easily, and without messing one's handswith the composition, and that will not run after it has been applied tothe skin. Moreover, the need still exists for such a composition thatcan be applied to the skin without the need to use high-pressure such asthat provided by propellant gas in an aerosol can. Furthermore, the needstill exists for a composition meeting all those criteria that can beused for treating diaper rash.

SUMMARY OF THE INVENTION

A composition that can satisfy some or all of those needs and providesother benefits that will be apparent to one skilled in the art has nowbeen developed. Broadly, the composition of this invention is askin-protectant composition comprising:

-   -   (a) at least about 0.001% w of at least one active ingredient        for protecting skin;    -   (b) at least about 0.001% w of at least one rheology modifier;        and    -   (c) carrier;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for protecting        the skin, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a skin-protectant compositioncomprising:

-   -   (a) at least about 0.001% w of at least one active ingredient        for protecting skin;    -   (b) at least about 0.001% w of a rheology modifier that is an        associative thickener and optionally at least about 0.001% w of        at least one additional rheology modifier; and    -   (c) carrier;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for protecting        the skin, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a skin-protectant compositioncomprising:

-   -   (a) at least about 0.001% w of at least one active ingredient        for protecting skin;    -   (b) at least about 0.001% w of a rheology modifier that is an        associative thickener and optionally at least about 0.001% w of        at least one additional rheology modifier;    -   (c) at least about 0.001% w of at least one film-forming agent;        and    -   (d) carrier;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for protecting        the skin, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a skin-protectant compositioncomprising:

-   -   (a) at least about 0.1% w of at least one active ingredient for        protecting skin;    -   (b) at least about 0.1% w of a rheology modifier that is an        associative thickener comprising silica and optionally at least        about 0.1% w of at least one additional rheology modifier;    -   (c) at least about 0.1% w of at least one polymeric film-forming        agent; and    -   (d) carrier;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for protecting        the skin, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a skin-protectant compositioncomprising:

-   -   (a) at least about 0.001% w of at least one active ingredient        for protecting skin;    -   (b) at least about 0.001% w of at least one rheology modifier        that is an associative thickener and optionally at least about        0.001% w of at least one additional rheology modifier that is a        wax;    -   (c) at least about 0.001% w of at least one polymeric        film-forming agent selected from the group consisting of        silicon-containing polymers and synthetic waxes; and    -   (d) carrier;    -   wherein the composition is liquid, water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for protecting        the skin, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a diaper rash compositioncomprising:

-   -   (a) at least about 0.1% w of at least one active ingredient for        treating diaper rash;    -   (b) at least about 0.1% w of at least one rheology modifier;    -   (c) at least about 0.1% w of at least one film-forming agent;        and    -   (d) carrier;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for treating        diaper rash, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a diaper rash compositioncomprising:

-   -   (a) at least about 1% w of dimethicone;    -   (b) at least about 0.5% w of at least one rheology modifier        selected from the group consisting of associative thickeners and        waxes;    -   (c) at least about 0.2% w of at least one polymeric film-forming        agent; and    -   (d) carrier;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for treating        diaper rash, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a diaper rash compositioncomprising:

-   -   (a) at least about 1% w of dimethicone;    -   (b) at least about 1% w of zinc oxide;    -   (c) at least about 1% w of wax;    -   (d) at least about 1% w of an associative thickener;    -   (e) at least about 0.2% w of at least one polymeric film-forming        agent; and    -   (f) carrier selected from the group consisting of mineral oil        and mineral oil replacements;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for treating        diaper rash, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a diaper rash compositioncomprising:

-   -   (a) at least about 1% w of dimethicone;    -   (b) at least about 1% w of mineral wax;    -   (c) at least about 0.5% w of silica;    -   (d) at least about 0.1% w of a silicon-containing polymeric        film-forming agent;    -   (e) at least about 0.1% w of a synthetic wax polymeric        film-forming agent;    -   (f) at least about 2% w cyclomethicone;    -   (g) at least about 2% w isohexadecane; and    -   (h) at least about 50% w mineral oil;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for treating        diaper rash, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a diaper rash compositioncomprising:

-   -   (a) from about 0.8% w to about 1.2% w of dimethicone;    -   (b) from about 4% w to about 6% w of mineral wax;    -   (c) from about 1.8% w to about 2.8% w of silica;    -   (d) from about 0.8% w to about 1.2% w of a silicon-containing        polymeric film-forming agent;    -   (e) from about 1.6% w to about 2.4% w of a synthetic wax        polymeric film-forming agent;    -   (f) from about 7.2% w to about 10.8% w cyclomethicone;    -   (g) from about 5.2% w to about 7.8% w isohexadecane; and    -   (h) from about 57% w to about 85% w mineral oil;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for treating        diaper rash, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a diaper rash compositioncomprising:

-   -   (a) at least about 1% w of dimethicone;    -   (b) at least about 1% w of zinc oxide;    -   (c) at least about 1% w of mineral wax;    -   (d) at least about 0.5% w of silica;    -   (e) at least about 0.1% w of a silicon-containing polymeric        film-forming agent;    -   (f) at least about 0.1% w of a synthetic wax polymeric        film-forming agent;    -   (g) at least about 2% w cyclomethicone;    -   (h) at least about 2% w isohexadecane; and    -   (i) at least about 50% w mineral oil;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for treating        diaper rash, has suitable adherence to the skin, and resists        running.

Another aspect of the invention concerns a diaper rash compositioncomprising:

-   -   (a) from about 0.8% w to about 1.2% w of dimethicone;    -   (b) from about 8% w to about 12% w of zinc oxide;    -   (c) from about 1.8% w to about 2.7% w of mineral wax;    -   (d) from about 1.7% w to about 2.5% w of silica;    -   (e) from about 0.4% w to about 0.6% w of a silicon-containing        polymeric film-forming agent;    -   (f) from about 1.0% w to about 1.6% w of a synthetic wax        polymeric film-forming agent;    -   (g) from about 6.8% w to about 10.2% w cyclomethicone;    -   (h) from about 4.5% w to about 6.7% w isohexadecane; and    -   (i) from about 53% w to about 80% w mineral oil;    -   wherein the composition is liquid, is water-repellent, is        substantially anhydrous, is spray-pumpable, is designed for        spraying onto the skin of a baby or other human for treating        diaper rash, has suitable adherence to the skin, and resists        running.

Another aspect of this invention concerns a hand-held spray pumpdispenser containing and for spraying the composition of this invention.

Another aspect of this invention concerns a method of protecting humanskin comprising applying the composition of this invention to humanskin.

Another aspect of this invention concerns a method of treating diaperrash in a human comprising applying the composition of this invention tohuman skin.

The composition of this invention is safe, effective, and can be applieddirectly to the skin (i.e., by spraying). Spraying obviates the need tofirst put the composition on one's hands or on an application device andthen rub it onto the skin of a baby or other human being. Such rubbingon skin already affected with, for example, diaper rash would likelycause discomfort. The composition of this invention is storage-stable,even though it can contain a significant concentration of solids, suchas zinc oxide particles. The composition can be sprayed using ahand-held pump sprayer (a hand-held spray pump dispenser), that is,without the need to use a pressurized (e.g., propellant-containing)device. Hand-held spray pump dispensers are easier to use, moreenvironmentally friendly, and their use avoids having a pressurizedcontainer used near, for example, an infant. The composition of thisinvention tends to resist running after it has been applied to the skin,and it has a reduced greasy feel.

Further aspects, features, and advantages of this invention will becomeapparent to those skilled in the art from the description of theinvention herein.

DETAILED DESCRIPTION OF THE INVENTION

The composition of this invention is a liquid, water-repellent,substantially anhydrous, spray-pumpable composition that is designed forspraying onto the skin of a baby or other human being for protectingskin (e.g., for treating diaper rash). It is believed that thiscomposition is the first skin protectant spray composition that, amongother things, is liquid, is designed for direct application to the skinof a human being (including to the tender skin of a baby), isefficacious in protecting the skin to which it is applied, has suitableadherence to the skin, can contain particles (e.g., of silica), isstorage-stable, water-repellent, substantially anhydrous, andspray-pumpable, and resists running. It is also believed that the diaperrash spray embodiment is the first diaper rash spray composition of itstype that, among other things, is liquid, is designed for directapplication to the tender skin of a baby, provides efficacious treatmentof diaper rash, has suitable adherence to the skin, can contain zincoxide particles, is storage-stable, water-repellent, substantiallyanhydrous, and spray-pumpable, and resists running.

By “liquid” is meant that at 20 degrees Centigrade under atmosphericpressure the substance in question hag a continuous liquid phase andotherwise meets the definition of a liquid. For example, the compositionof this invention is liquid before being sprayed because it has acontinuous liquid phase at 20 degrees Centigrade under atmosphericpressure. Thus, for example, the presence of solid particles (e.g., ofzinc oxide and/or silica) in the composition does not prevent it frombeing considered to be a “liquid” composition.

By “water-repellent” is meant that the composition when on the skinsubstantially impedes the passage of liquid water through thecomposition for a sufficiently long period of time. Thus, for example,in the case of a diaper rash composition of this invention, thecomposition is water-repellent because it impedes the passage of waterfor at least what is a typical period of time between diaper changes(e.g., three hours, five hours, seven hours, or in some cases evenlonger).

By “substantially anhydrous” is meant that the water content of thecomposition will be less than about 5% w by weight, typically less thanabout 3% w, desirably less than about 2% w, more desirably less thanabout 1% w, most desirably less than about 0.5% w, preferably less thanabout 0.3% w, more preferably less than about 0.1% w, and mostpreferably less than about 0.05% w. Although no water preferably isintentionally added as a separate ingredient when making thecomposition, it is possible that some of the ingredients used toformulate the composition may contain trace quantities of water. If anywater is present in the composition of this invention, there desirablyis no “free” (i.e., non-emulsified) water and, therefore, theredesirably is no separate water phase. Thus, preferably, at least as maybe observed using normal human vision (i.e., 20/20) without the aid ofany magnifying or detection equipment, no separate aqueous layer formswhen the composition of this invention stands for 24 hours at 20 degreesCentigrade in a closed container padded with inert gas.

The presence of free water in the composition tends to adversely affectthe physical and other properties of the composition. More free watercould create a discrete water layer and/or increase the surface tensionof the composition (reducing the ability of the composition to “wet” theworking parts of the spray pump dispenser and thereby be easily sprayed)and/or decrease the composition's adherence to the skin (tackiness)and/or increase its “runnyness” (i.e., the tendency of the compositionto run off the skin to which it has been applied because of gravity orother force). Thus, free (i.e., non-emulsified) water in a layer ofcomposition on skin being protected (which includes being treated) isbelieved to reduce the efficacy of the composition for its intendedpurpose of protecting skin (e.g., treating diaper rash) by reducing thesprayability of the composition, by reducing the barrier properties ofthe composition (including making the composition less water-repellent),and by making it easier for the composition to prematurely leave theskin being treated (e.g., to prematurely rub off or prematurely flow offunder the force of gravity). If the composition were formulated tocontain water, it would be necessary to add an emulsifier; however, itis a feature of this invention that the composition can be“emulsifier-free.” Preferably the composition is emulsifier-free.Including an emulsifier in the composition (so that any water present isnot “free”) would tend to make the composition less spray-pumpable andless water-repellent, and it is a feature of this invention that thecomposition is spray-pumpable and water-repellent.

By “spray-pumpable” is meant that a hand-held spray pump dispenser canbe used to dispense the composition, which is liquid at 20 degreesCentigrade under normal atmospheric pressure, by spraying using normalfinger pressure on the portion of the spray pump assembly designed to beactivated by finger pressure. By “spray” is meant a jet of finelydivided liquid composition. (See, e.g., U.S. Pat. Nos. 3,159,316,4,034,900, and 4,050,860, which show different spray pump dispensers.)The hand-held spray pump dispenser used to dispense (spray) acomposition of this invention typically contains the composition atatmospheric pressure and it is only when finger pressure is applied thatthe spray pump mechanism temporarily pressurizes the composition tocause a portion of it to leave the dispenser as a spray. The pressure inthe mechanism soon returns to atmospheric after the small portion ofcomposition has been dispensed. Such a hand-held spray pump dispenser isconsidered to be a non-pressurized dispenser. In other words, a featureof this invention is that a hand-held spray pump dispenser (i.e., anon-pressurized dispenser) can be used in its normal manner to dispensethe composition of this invention.

“Spray cans” or “aerosol cans,” which use propellants (e.g., a FREON orother fluid having a vapor pressure at 20 degrees Centigradesignificantly higher than atmospheric pressure), are well-known types ofpressurized dispensers. Another type of pressurized dispenser is onehaving a resilient deformable bladder that has been force-filled withenough mass to cause it to expand. The memory of the resilient bladdermaterial causes it to try to return to its original, non-deformed sizeand shape, which thereby pressurizes the mass inside the bladder.Another type of pressurized dispenser is a motor-driven pump (e.g., acentrifugal pump, a positive displacement pump).

The higher pressures that are provided by pressurized dispensers are notneeded to dispense (spray) the composition of this invention, althoughin some cases they may be used. The fact that a spray-pumpablecomposition of this invention is also able to be dispensed using apressurized dispenser (e.g., a dispenser containing a propellant, adispenser containing a resilient expanded bladder, a motor-driven pump)does not mean that the composition is not spray-pumpable; however,hand-held spray pump dispensers (i.e., non-pressurized dispensers) arepreferred for use in spraying the composition of this invention onto theskin to be treated. Broadly speaking, hand-held spray pump dispensersare less expensive, more economical, and more environmentally friendlythan pressurized dispensers.

It is not believed that any special design for the hand-held spray pumpdispenser is needed, although some adjustment of specific dimensionsand/or materials of construction may be needed because of the physicaland chemical properties of the particular composition to be dispensed.As will be understood by those skilled in the art, the particular designof the spray pump dispenser is not critical and any hand-held spray pumpdispenser that allows appropriate dispensing of the composition of thisinvention, in which the composition is sufficiently storage-stable, andwhich itself is not adversely affected by the composition (e.g., byprolonged storage) can be used. Broadly speaking, spray pump dispensersare affected to some degree by the compositions they contain anddispense. For example, storage of the composition in the spray pumpdispenser in warm weather over an extended period may cause swelling ofthe different parts of the spray pump dispenser to differing degrees.That in turn may adversely affect operation of the spray pump anddispensing (spraying) of the composition. Selection of a hand-held spraypump dispenser design and of suitable materials of construction are wellwithin the skill of the art.

The terms “protecting skin,” “protecting the skin,” and “protectinghuman skin” are synonymous, have been defined above, and each includeprotecting and/or treating skin in connection with various indicationsinvolving the skin, including diaper rash; minor burns; cuts; scrapes;sunburn; chaffed, chapped, cracked, or windburned skin or lips; skinirritation; and oozing and/or weeping of skin caused by poison ivy,poison oak, and/or poison sumac.

The term “diaper rash” has been defined above as an inflammatory skincondition in the diaper area (perineum, buttocks, lower abdomen, andinner thighs) caused by one or more of the following factors: moisture,occlusion, chaffing, continued contact with urine or feces or both, ormechanical or chemical irritation. Thus, “diaper rash” is the well-knowncondition often suffered by babies and older incontinent people as aresult of their wearing diapers or the like (e.g., incontinence pads).Diaper rash may also be referred to as “diaper dermatitis” or“incontinence dermatitis.”

The term “treating diaper rash” has been defined above and includestreating an existing diaper rash condition or preventing a diaper rashcondition or both.

A composition that is “designed for spraying onto the skin of a baby orother human” is a sprayable composition that will not harm the skin ofany human being, not even the more delicate (tender) skin of a baby,will not be toxic, will not cause irritation, will not be malodorous,will not decompose to cause any harmful reactions, will not adverselyaffect any diaper or other substrate that may be in contact with thecomposition, etc. Compositions “designed for spraying onto the skin of ababy or other human” include compositions designed to be sprayed ontothe skin of babies or other human beings for any indication for which askin protectant is used.

A composition that is “designed for spraying onto the skin of a baby orother human for protecting the skin” is a composition that is “designedfor spraying onto the skin of a baby or other human” and is efficaciousfor the purpose of protecting the skin.

A composition that is “designed for spraying onto the skin of a baby orother human for treating diaper rash” is a composition that is “designedfor spraying onto the skin of a baby or other human” and is efficaciousfor the purpose of treating diaper rash.

A composition of this invention that has “suitable adherence to theskin” will after being applied to the skin remain adhered to the skinlong enough under normal conditions of use to have an efficacious effect(for example, for treating diaper rash). A layer of composition on theskin may be thought of as a stack of parallel thin layers, each layerbeing at least one molecule thick. With a composition that has suitableadherence to the skin, the composition's molecular layer closest to theskin (the bottom molecular layer) will temporarily bond physicallyand/or chemically to the skin on a molecular level, the composition'smolecular layer above the bottom molecular layer will temporarily bondphysically and/or chemically to that bottom molecular layer, and so on.The bonds between the skin and the bottom molecular layer and betweenthe successive molecular layers cannot be permanent or else it would bedifficult to remove the composition from the skin.

If a composition “resists running,” the composition will not, forexample, under the force of gravity, easily or quickly flow from theskin to which it has been applied. The ability to “resist running” inany particular case depends not only on the physical and chemicalproperties of the composition itself, but also on variables such as thethickness of the layer of composition applied to the skin and thecondition (e.g., oiliness, cleanliness) of the skin to which thecomposition was applied. The rheology modifiers, optional film-formingagents, and optional volatile carrier ingredients used in thecomposition help it resist running.

The ability of a composition of this invention to resist running wascompared to the ability of two compositions outside the scope ofinvention to resist running. All of the test runs were performed at roomtemperature (about 20 degrees Centigrade). The preferred zincoxide-containing composition of this invention (described in detailbelow) was placed in a dispenser that dispenses as a spray nominally0.13 milliliters of composition per pump. The spray nozzle was held 2inches (about 5.1 centimeters) above a piece of FORMICA plastic laminatelying flat on a horizontal work surface so that the centerline of thedispensing aperture in the nozzle was perpendicular to the surface ofthe laminate, and three “pumps” of composition were dispensed (a totalof nominally 0.39 milliliters of composition). The resulting circleformed on the laminate surface by the sprayed composition was 1.5 inches(about 3.8 centimeters) in diameter. The piece of plastic laminate wasrotated to a vertical position so that the plane of the circle wasperpendicular to the horizontal work surface, and a line 4 inches (about10.2 centimeters) below the bottom of the circle and parallel to thehorizontal work surface was established. The preferred zincoxide-containing composition of this invention did not run down from its1.5-inch circle, much less traverse the 4 inches (about 10.2centimeters), even after 2 hours.

The test was also performed on two compositions outside the scope of theinvention: (1) a liquid consisting of only the mineral oil used in thepreferred zinc oxide-containing composition and (2) a liquid consistingof 99% w of that mineral oil and 1% w of the dimethicone used in thepreferred zinc oxide-containing composition. The 100% w mineral oilflowed down the surface of the plastic laminate and traversed thedistance of 4 inches (about 10.2 centimeters) in less than a second. Theliquid consisting of 99% w mineral oil and 10% w dimethicone flowed downthe surface of the plastic laminate and traversed the distance of 4inches (about 10.2 centimeters) in about 4 seconds.

As used herein, the term “resists running” means that when a compositionis tested in this manner, if it is going to flow at all, it requires atleast about 10 seconds to traverse (flow down) the 4 inches (in otherwords, it “resists running for at least about 10 seconds”), usually atleast about 15 seconds to traverse the 4 inches (it “resists running forat least about 15 seconds”), typically at least about 20 seconds totraverse the 4 inches (it “resists running for at least about 20seconds”), desirably at least about 30 seconds to traverse the 4 inches(it “resists running for at least about 30 seconds”), more desirably atleast about 45 seconds to traverse the 4 inches (it “resists running forat least about 45 seconds”), most desirably at least about 1 minute totraverse the 4 inches (it “resists running for at least about 1minute”), preferably at least about 2 minutes to traverse the 4 inches(it “resists running for at least about 2 minutes”), more preferably atleast about 5 minutes to traverse the 4 inches (it “resists running forat least about 5 minutes”), most preferably at least about 10 minutes totraverse the 4 inches (it “resists running for at least about 10minutes”), and in some cases, it requires at least about 30 minutes totraverse the 4 inches (it “resists running for at least about 30minutes”). The most preferred compositions do not traverse the 4 incheseven after an hour or more and therefore may be said to “resist running”(they “resist running for at least about 1 hour”).

These tests demonstrate that the preferred zinc oxide-containingcomposition of this invention “resists running” and that neither of theother two compositions that were tested “resists running.” The lattertwo compositions are outside the scope of the invention because, forexample, neither contains a rheology modifier and neither resistsrunning. The test performed with the preferred zinc oxide-containingcomposition also demonstrates that it has suitable adherence to theskin.

The composition of this invention has the appropriate rheology to bespray-pumpable (i.e., to have a low enough viscosity under shear) aswell as to resist running after it has been applied to skin (i.e., tohave a high enough viscosity when not under shear). That arises in partfrom the fact that one or more rheology modifiers are used to make theviscosity of the composition generally decrease as the shear on itincreases (i.e., the composition may be pseudoplastic or thixotropic).Thus, as the composition that had been at rest (i.e., not flowing) inthe spray pump dispenser starts to move, for example, up a tube insidethe spray pump dispenser, the shear increases and the viscosity of thecomposition decreases. As the composition continues to move, forexample, in a narrowing passage towards the small aperture in the nozzleof the spray pump dispenser, the shear continues to increase and theviscosity continues to decrease. The shear may be at a maximum, and theviscosity at a minimum, as the composition passes through the aperturein the nozzle and leaves the spray pump dispenser.

After the composition comes to rest on the skin, the force being appliedto the composition is substantially less than when the composition wasbeing forced to move inside the spray pump dispenser and through theaperture. Accordingly, the viscosity of the composition on the skin maybecome essentially the same as the viscosity of the composition when itwas at rest inside the spray pump dispenser (and may become even higherif volatile carrier ingredients evaporate, which is what desirablyhappens with the compositions of this invention). This return to higherviscosity as the shear decreases plus the optional use of one or morefilm-forming agents help the composition resist running on the skin. Inshort, a “rheology modifier” is a substance otherwise suitable forincorporation into a composition of this invention that helps impart tothe composition the needed transport properties and make it, forexample, pseudoplastic or thixotropic.

Broadly, the composition of this invention contains at least one activeingredient for protecting skin, at least one rheology modifier, and acarrier. A preferred embodiment of this invention contains at least oneactive ingredient for treating diaper rash, at least one rheologymodifier, and a carrier. The composition of this invention desirablyalso contains at least one film-forming agent. Various optionalingredients include colorants, fragrances, anti-microbials,preservatives, emollients, conditioners, adherence-promoting agents,water-resistance agents, and water-proofing agents.

The term “active ingredients for protecting skin” includes mineral oil,dimethicone, zinc oxide, allantoin, calamine, kaolin, petrolatum, whitepetrolatum, cod liver oil, lanolin, talc, topical starch, aluminumhydroxide gel, cocoa butter, glycerine, shark liver oil, zinc acetate,and zinc carbonate. The term “active ingredients for protecting skin”also includes other substances that are now or may in the future beefficacious for protecting skin, provided they can be successfully usedalone or in combination with other active ingredients to form acomposition of this invention.

The term “active ingredients for treating diaper rash” includes mineraloil, dimethicone, zinc oxide, allantoin, calamine, kaolin, petrolatum,white petrolatum, cod liver oil, lanolin, talc, and topical starch. Theterm “active ingredients for treating diaper rash” also includes othersubstances that are now or may in the future be efficacious for treatingdiaper rash, provided they can be successfully used alone or incombination with other active ingredients to form a composition of thisinvention. Of the active ingredients listed above, dimethicone ispreferred and a combination of dimethicone and zinc oxide is mostpreferred.

The concentration of the one or more active ingredients for protectingskin should be at least about 0.001% w, usually at least about 0.01% w,desirably at least about 0.1% w, and preferably at least about 1% w. Insome cases, the concentration will be at least about 5% w, at leastabout 10% w, or even at least about 50% w. The FDA allows a claim to bemade that dimethicone is present in a composition as an activeingredient for treating diaper rash if its concentration in thecomposition in question is from 1% w to 30% w (and providing other FDArequirements are met). The corresponding range for zinc oxide undercurrent FDA regulations is from 1% w to 40% w. The corresponding rangefor mineral oil is from 50% w to 100% w.

The limitation “at least about 0.001% w of at least one activeingredient for protecting skin” is satisfied or met (a) if any activeingredient for protecting skin is present in a concentration of at leastabout 0.001% w or (b) if two or more active ingredients for protectingskin are present in a total concentration of at least about 0.001% weven if none of the active ingredients for protecting skin isindividually present in a concentration of at least about 0.001% w.Similarly, the limitation “at least about 0.1% w of at least one activeingredient for treating diaper rash” is satisfied or met (a) if anyactive ingredient for treating diaper rash is present in a concentrationof at least about 0.1% w or (b) if two or more active ingredients fortreating diaper rash are present in a total concentration of at leastabout 0.1% w even if none of the active ingredients for treating diaperrash is individually present in a concentration of at least about 0.1%w. In the same way, the limitation “at least about 0.001% w of at leastone rheology modifier” is satisfied or met (a) if any rheology modifieris present in a concentration of at least about 0.001% w or (b) if twoor more rheology modifiers are present in a total concentration of atleast about 0.001% w even if none of the rheology modifiers isindividually present in a concentration of at least about 0.001% w.

Other limitations specifying at least a certain weight percent of atleast one of a certain type of ingredient should be understood that sameway (making allowances, of course, for different numerical limits andtypes of ingredients). For example, the limitation “at least about 0.1%w of at least one film-forming agent” is satisfied or met (a) if anyfilm-forming agent is present in a concentration of at least about 0.1%w or (b) if two or more film-forming agents are present in a totalconcentration of at least about 0.1% w even if none of the film-formingagents is individually present in a concentration of at least about 0.1%w.

If dimethicone is used, it will typically be present in the compositionin a concentration range of about 0.01% w to about 30% w, desirably in arange of about 0.1% w to about 10% w, and preferably in a range of about0.2% w to about 3% w. If zinc oxide is used, it will typically bepresent in a concentration range of about 0.01% w to about 40% w,desirably in a range of about 0.1% w to about 20% w, and preferably in arange of about 00.2% w to about 15% w. If mineral oil is used, it willtypically be present in the composition in a concentration range ofabout 10% w to about 99% w, desirably in a range of about 50% w to about85% w, and preferably in a range of about 55% w to about 80% w.

The dimethicone used will desirably be a crystal clear viscous liquid,free from suspended matter, and with very little odor. Any dimethiconecan be used. One dimethicone found suitable has a viscosity in the rangeof about 333 to about 368 centistokes when measured using a UbbelhodeSize 3 viscometer at 25 degrees Centigrade and a specific gravity ofabout 0.96 to about 0.98 (25 degrees Centigrade/25 degrees Centigrade).

The zinc oxide used will desirably be a high purity USP (United StatesPharmacopoeia) zinc oxide with a typical particle size of about 0.11microns, a maximum particle size of about 0.14 microns, a minimumsurface area (BET) of about 8 square meters per gram, a typical surfacearea (BET) of about 9 square meters per gram, a bulk density of about 50pounds per cubic foot (0.80 grams per cubic centimeter), an apparentdensity of about 16 pounds per cubic foot (0.26 grams per cubiccentimeter), and with about 99.99% of the particles passing through a325 mesh screen. Thus, the zinc oxide used herein will typically have anaverage particle size of less than about 1 micron (desirably less thanabout 0.75 microns, more desirably less than about 0.50 microns, mostdesirably less than about 0.25 microns, preferably less than about 0.20microns, and more preferably less than about 0.15 microns) and a BETsurface area of at least about 5 square meters per gram. The zinc oxideparticle size (and the size of any other particulates in thecomposition) should not be so large as to prevent the composition frombeing spray-pumpable.

The mineral oil is desirably light mineral oil NF (National Formulary)and is a colorless, odorless, transparent oil liquid. Its viscosity willdesirably be in the range of about 7 to about 10 centistokes whenmeasured using a Ubbelhode Size 2 viscometer at 40 degrees Centigrade,with a specific gravity of about 0.83 to about 0.84 (25 degreesCentigrade/25 degrees Centigrade).

The concentration of the one or more rheology modifiers should be atleast about 0.001% w, usually at least about 0.01% w, desirably at leastabout 0.1% w, and preferably at least about 1% w. In some cases, theconcentration will be at least about 5% w, at least about 110% w, oreven at least about 20% w.

The term “rheology modifier” includes waxes and associative thickeners.The term “rheology modifier” also includes other substances that are nowor may in the future be useful as rheology modifiers, provided they canbe successfully used alone or in combination with other rheologymodifiers to form a composition of this invention. The one or morerheology modifiers help impart the desired transport properties to thecomposition, that is, they help make the composition for example,pseudoplastic or thixotropic, so that it is spray-pumpable but able toresist running after it has been applied to the skin.

The wax, if used, is desirably a mineral wax. If mineral wax is used, itwill typically be present in the composition in a concentration range ofabout 0.01% w to about 20% w, desirably in a range of about 0.1% w toabout 15% w, and preferably in a range of about 0.2% w to about 6% w.The mineral wax will typically be a white to yellowish odorless waxysolid, desirably having a melting range of from about 65 degreesCentigrade to about 71 degrees Centigrade.

The associative thickener, if used, desirably comprises a silica andpreferably colloidal silicon dioxide NF (National Formulary). Itsparticle size cannot be so large as to prevent the composition frombeing spray-pumpable.

Desirably the mineral wax and colloidal silicon dioxide are both used.The wax helps give the composition some body, provides internalcohesiveness (internal tack) to the layer of composition on the skin(which facilitates removal from the skin), and provides waterrepellency, in addition to acting as a rheology modifier. The colloidalsilicon dioxide acts as a rheology modifier and if zinc oxide is presentin the composition, the silicon dioxide helps to suspend the zinc oxideparticles. As between these two types of rheology modifiers (waxes andassociative thickeners), the associative thickeners are believed to playa larger role in giving the composition of this invention the desiredtransport properties to make it, for example, pseudoplastic orthixotropic.

The carrier can comprise more than one ingredient. The concentration ofthe carrier in the composition should be at least about 10% w, usuallyat least about 20% w, desirably at least about 30% w, preferably atleast about 40% w, more preferably at least about 50% w, and mostpreferably at least about 60% w.

The term “carrier” includes mineral oil and mineral oil replacements.The term “carrier” also includes other substances that are now or may inthe future be useful as carriers, provided they can be successfully usedalone or in combination with other carrier ingredients to form acomposition of this invention.

Mineral oil replacements include alkanes having at least 10 carbon atoms(e.g., isohexadecane), benzoate esters, aliphatic esters, noncomodogenicesters, volatile silicone compounds (e.g., cyclomethicone), and volatilesilicone substitutes. Examples of benzoate esters include Cl₂-C₁₅ alkylbenzoate, isostearyl benzoate, 2-ethyl hexyl benzoate, dipropyleneglycol benzoate, octyldodecyl benzoate, stearyl benzoate, and behenylbenzoate.

Examples of aliphatic esters include C₁₂-C₁₅ alkyl octonoate and dioctylmaleate. Examples of noncomodogenic esters include isononylisononanoate, isodecyl isononanoate, diisostearyl dimer dilinoleate,arachidyl propionate, and isotridecyl isononanoate. Examples of volatilesilicone substitutes include isohexyl decanoate, octyl isononanoate,isononyl octanoate, and diethylene glycol dioctanoate.

If mineral oil is used, it will typically be present in the compositionin a concentration range of about 10% w to about 99% w, desirably in arange of about 50% w to about 85% w, and preferably in a range of about55% w to about 80% w.

If isohexadecane is used, it will typically be present in thecomposition in a concentration range of about 0.01% w to about 50% w,desirably in a range of about 0.1% w to about 15% w, and preferably in arange of about 0.2% w to about 10% w. The isohexadecane helps reduce thegreasiness of the composition that might be felt if it were not present.Isohexadecane by itself tends to feel “dry” and not greasy.

If cyclomethicone is used, it will typically be present in thecomposition in a concentration range of about 0.01% w to about 99% w,desirably in a range of about 0.1% w to about 20% w, and preferably in arange of about 0.2% w to about 15% w. Cyclomethicone is an evaporativesilicone and it helps make the composition spray-pumpable. Furthermore,after the composition is dispensed and contacts the skin, thecyclomethicone tends to evaporate, thereby helping to the composition toresist running and thereby fix the composition on the skin on which itwas sprayed.

Preferably the carrier comprises a combination of mineral oil,isohexadecane, and cyclomethicone.

Desirably at least one film-forming agent is used in the composition.The concentration of the one or more film-forming agents should be atleast about 0.001% w, usually at least about 0.01% w, desirably at leastabout 0.1% w, more desirably at least about 0.2% w, preferably at leastabout 1% w, and more preferably at least about 2% w. In some cases, theconcentration will be at least about 5% w, at least about 10% w, or evenat least about 20% w.

The term “film-forming agent” includes polymers such assilicone-containing polymers and synthetic waxes. The term “film-formingagent” also includes other substances that are now or may in the futurebe useful as film-forming agents, provided they can be successfully usedalone or in combination with other film-forming agents to form acomposition of this invention.

The silicone-containing polymers that are useful herein will typicallyhave silicone-seeking groups and hydrophobic groups. An example of asilicone-containing polymer that may be used as a film-forming agent isa polydimethylsiloxane-polypropylene glycol ether/isopropyldiisocyanatecopolymer, which is a silicone polyurethane and is described as asemi-clear faint yellow viscous liquid. Such a material is marketedunder the name Polyderm PPI-SI-WI by Alzo Inc., located in Matawan,N.J., United States. If that silicone-containing polymer is used, itwill typically be present in the composition in a concentration range ofabout 0.01% w to about 15% w, desirably in a range of about 0.1% w toabout 10% w, and preferably in a range of about 0.2% w to about 3% w.This polymer functions not only as a film-forming agent but also is aconditioner and emollient, helps impart water-resistance, and helpsprovide adherence of the composition to the skin. This polymer alsohelps couple the silicone-containing components present (e.g.,dimethicone and cyclomethicone) to the non-silicone-containingingredients present (e.g., mineral oil).

An example of a synthetic wax that may be used as a film-forming agentis described as a highly branched hydrocarbon manufactured from olefins.A suitable synthetic wax may have a polydispersity of about 2.4, anumber average molecular weight of about 900, and a weight averagemolecular weight of about 2,200. One such suitable material is marketedunder the name Performa V 825 Polymer by New Phase Technologies locatedin Piscataway, N.J., United States. The company's “NPT TechnicalBulletin 6825-1” (revision dated 3/99) describes the material as “anexcellent film former and conditioner,” which “provides gloss tolipsticks and improves the rheology of sunscreen formulations.” If thatsynthetic wax is used, it will typically be present in the compositionin a concentration range of about 0.01% w to about 30% w, desirably in arange of about 0.1% w to about 10% w, and preferably in a range of about0.2% w to about 6% w. This synthetic wax functions not only as afilm-forming agent but also helps impart water-resistance.

Many different optional ingredients may be included in the composition,including colorants, fragrances, anti-microbials, preservatives,emollients, conditioners, adherence-promoting agents, water-resistanceagents, and water-proofing agents. For example, an aloe barbadensisproduct may be included as may vitamins such as vitamin E. An aloeproduct, if used in the composition, will typically be present in thecomposition in a concentration range of about 0.01% w to about 15% w,desirably in a range of about 0.1% w to about 10% w, and preferably in arange of about 0.2% w to about 6% w. Vitamin E, if used in thecomposition, will typically be present in the composition in aconcentration range of about 0.01% w to about 5% w, desirably in a rangeof about 0.1% w to about 3% w, and preferably in a range of about 0.2% wto about 1% w, and may be added in its acetate ester form.

A preferred composition without zinc oxide and a preferred compositionwith zinc oxide are shown below (numerical values are weightpercentages). Preferred Composition Preferred Composition IngredientWithout Zinc Oxide With Zinc Oxide Mineral Oil 70.95 66.50 PolydermPPI-SI-WI 1.00 0.50 Dimethicone 1.00 1.00 Mineral Wax 5.00 2.25 PerformaV 825 Polymer 2.00 1.30 Colloidal Silicon Dioxide 2.30 2.10Cyclomethicone 9.00 8.50 Isohexadecane 6.50 5.60 Aloe BarbadensisExtract 2.00 2.00 Vitamin E Acetate 0.25 0.25 Zinc Oxide 0.00 10.00Total 100.00 100.00

A typical process for manufacturing the preferred composition with zincoxide is as follows. The first five ingredients (mineral oil, PolydermPPI-SI-WI, dimethicone, mineral wax, and Performa V 825 Polymer) areplaced in a suitable stainless steel container and heated to about 80degrees Centigrade while mixing at slow speed. After the mineral waxmelts, heating is halted and the zinc oxide is added while mixing atabout 500 RPM (revolutions per minute) for at least 10 minutes. When thebatch cools to about 50 degrees Centigrade (while still mixing), thecolloidal silicon dioxide is added and the mixing speed is increased toabout 2,000 RPM and held at that speed for at least 20 minutes. Theremaining ingredients (cyclomethicone, isohexadecane, aloe barbadensisextract, and vitamin E acetate) are then added and mixing is continuedfor about 15 minutes. At the end of this time, the material is milled tofurther homogenize it and the manufacture is then complete. To make thepreferred composition that does not contain the zinc oxide, the processis essentially the same, the major difference being that the step inwhich the zinc oxide is added is omitted. The processes for making othercompositions of the invention are well within the skill of the art.

When the composition contains solid suspended particles (e.g., the zincoxide and/or colloidal silica), it might be seem to be more appropriateto refer to the composition as a dispersion or suspension rather than asa liquid. However, even though solid particles may be present, thecomposition of this invention will still be referred to as a “liquid”because (a) the continuous phase of the composition is liquid andtypically will account for the majority of the composition (andpreferably about 90% w of it) and (b) the user will likely perceive sucha composition as being “liquid.”

For a variety of reasons, such a dispersion or suspension is desirablystorage-stable, that is, the particles desirably do not settle out, evenafter prolonged standing. When zinc oxide particles are present, thesilica (e.g., colloidal silicon dioxide) helps prevent their settling.If particles do settle out, they should be readily and easilyredispersable and resuspendable, preferably merely by shaking thecomposition a few times.

As will be apparent, a single ingredient can perform more than a singlefunction in a composition of this invention. Thus, it should beunderstood in applying the claims to a given composition that because aningredient of the composition may perform more than one function, thatone ingredient may thereby satisfy (or meet) more than one limitation ofa claim. For example, mineral oil, which can act as an activeingredient, is also a preferred carrier. If mineral oil is present in acomposition in at least the minimum concentration for an activeingredient for protecting skin specified by the limitation of a givenclaim, then the mineral oil of that composition meets that claimlimitation. If the mineral oil is also present in that composition in atleast the minimum concentration specified for the carrier by anotherlimitation of the same claim, then the mineral oil of that compositionalso meets that limitation of the claim. Thus, the same ingredient andamount of ingredient can satisfy more than a single limitation of aclaim. (If no numerical minimum is specified in a claim limitation thatrequires the presence of an ingredient, for example, a limitation thatjust requires “carrier,” that limitation is satisfied (or met) if atleast some of the ingredient is present.)

Variations and modifications will be apparent to those skilled in theart and the claims are intended to cover all modifications andvariations that fall within the true spirit and scope of the invention.

1. A skin-protectant composition comprising: (a) at least about 0.001% wof at least one active ingredient for protecting skin; (b) at leastabout 0.001% w of at least one rheology modifier; and (c) carrier;wherein the composition is liquid, is water-repellent, is substantiallyanhydrous, is spray-pumpable, is designed for spraying onto the skin ofa baby or other human for protecting the skin, has suitable adherence tothe skin, and resists running.
 2. The composition of claim 1 wherein theat least one active ingredient is selected from the group consisting ofmineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin,petrolatum, white petrolatum, cod liver oil, lanolin, talc, topicalstarch, aluminum hydroxide gel, cocoa butter, glycerine, shark liveroil, zinc acetate, and zinc carbonate.
 3. The composition of claim 1wherein the at least one rheology modifier comprises wax.
 4. Thecomposition of claim 3 wherein the wax comprises mineral wax.
 5. Thecomposition of claim 4 wherein the mineral wax has a melting range offrom about 65 degrees Centigrade to about 71 degrees Centigrade.
 6. Thecomposition of claim 1 wherein the at least one rheology modifiercomprises an associative thickener.
 7. The composition of claim 6wherein the associative thickener comprises silica.
 8. The compositionof claim 7 wherein the silica comprises colloidal silicon dioxide. 9.The composition of claim 1 wherein the at least one rheology modifiercomprises wax and an associative thickener.
 10. The composition of claim9 wherein the wax comprises mineral wax and the associative thickenercomprises silica.
 11. The composition of claim 10 wherein the mineralwax has a melting range of from about 65 degrees Centigrade to about 71degrees Centigrade and the silica comprises colloidal silicon dioxide.12. The composition of claim 1 wherein the carrier comprises mineral oilor a mineral oil replacement.
 13. The composition of claim 12 whereinthe carrier comprises a mineral oil replacement selected from the groupconsisting of alkanes having at least 10 carbon atoms, benzoate esters,aliphatic esters, noncomodogenic esters, volatile silicone compounds,and volatile silicone substitutes.
 14. The composition of claim 1further comprising at least one film-forming agent.
 15. (canceled) 16.The composition of claim 15 wherein the polymer comprises asilicon-containing polymer.
 17. The composition of claim 15 wherein thepolymer comprises synthetic wax.
 18. (canceled)
 19. The composition ofclaim 18 wherein the active ingredient is selected from the groupconsisting of mineral oil, dimethicone, zinc oxide, allantoin, calamine,kaolin, petrolatum, white petrolatum, cod liver oil, lanolin, talc, andtopical starch.
 20. A skin-protectant composition comprising: (a) atleast about 0.001% w of at least one active ingredient for protectingskin; (b) at least about 0.001% w of a rheology modifier that is anassociative thickener and optionally at least about 0.001% w of at leastone additional rheology modifier; and (c) carrier; wherein thecomposition is liquid, is water-repellent, is substantially anhydrous,is spray-pumpable, is designed for spraying onto the skin of a baby orother human for protecting the skin, has suitable adherence to the skin,and resists running. 21-23. (canceled)
 24. The composition of claim 20wherein the at least one additional rheology modifier is present in thecomposition and comprises wax. 25-33. (canceled)
 34. A skin-protectantcomposition comprising: (a) at least about 0.001% w of at least oneactive ingredient for protecting skin; (b) at least about 0.001% w of arheology modifier that is an associative thickener and optionally atleast about 0.001% w of at least one additional rheology modifier; (c)at least about 0.001% w of at least one film-forming agent; and (d)carrier; wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running. 35-78. (canceled)